Chemical Engineering Intern - NTP Radioisotopes SOC Ltd - Radiochemical API Production Department
(2025-02 - 2026-01)
Completed 12-month internship programme in Chemical Engineering with NTP Radioisotopes SOC Ltd in the Radiochemical API Production Department
- Ensured compliance with facility license conditions, cGMP, GDP, GDocP, DMF requirements, and applicable nuclear, pharmaceutical, and nuclear medicine regulatory frameworks
- Executed API production processes safely, efficiently, and consistently in accordance with approved SOPs and customer specifications
- Ensured that all production activities met defined safety, quality, radiological, and operational performance standards prior to batch release
- Maintained accurate, traceable, and auditable production and quality documentation in line with data integrity and Good Documentation Practice (GDP) principles
- Ensured continuous compliance with nuclear safety, radiological protection, and pharmaceutical production requirements through strict adherence to approved operating limits and procedures
- Performed comprehensive plant pre-checks and system readiness verifications, including production system inlet valves, reagent tanks, tank sieves, hot-cell pressure balances, hydrogen analysers, rotameters, dispensing systems, radiation monitoring systems, and waste management systems prior to production start-up
- Trained in, demonstrated proficiency, and efficiently mastered the use of hot-cell robotic manipulators, safely executing API production operations within shielded environments while maintaining radiological protection, contamination control, and process accuracy
- Operated and monitored the Human-Machine-Interface (HMI) to safely control critical process parameters, including nitrogen gas feeding, reagent dosing, system sequencing, interlocks, and alarms, in strict accordance with approved nuclear facility procedures
- Conducted sampling of nuclear medicine process batches in compliance with NTP and NECSA requirements, ensuring sample integrity, correct identification, traceability, and adherence to radiological and quality controls
- Performed daily verification and functional checks of calibrated and validated production equipment, including ionisation chambers, radiation monitors, and balances, ensuring accuracy and compliant record generation
- Executed safe handling, dispensing, and packaging of API product batches, ensuring shielding integrity, contamination control, correct labelling, and compliance with customer and regulatory requirements
- Ensured continuous compliance with Radiation Protection Officers (RPOs), actively monitoring and maintaining radiation levels within approved limits, and responding appropriately to radiological alarms or deviations
- Executed sampling, dispensing, and packaging of Active Pharmaceutical Ingredients (APIs) in compliance with ICH and cGMP guidelines, ensuring readiness for downstream Mo-99 use
- Verified batch compliance against defined specifications, including Radiochemical Purity (RCP), Radionuclidic Purity (RNP), pH, appearance, and activity concentration, prior to batch disposition and release for API supply
- Ensured accurate and compliant dispensing of customer orders within defined ODMS cut-off timelines, supporting uninterrupted supply to customers
- Executed documented post-production clean-up activities within hot cells and production areas, ensuring readiness for subsequent production campaigns and compliance with API and manufacturing standards
- Reported plant, instrumentation, and equipment maintenance-related issues promptly to support operational reliability and nuclear facility availability
- Coordinated closely with Quality Assurance (QA) and Quality Control (QC) departments at NTP, maintaining effective working relationships to support consumable requests, sample submissions, testing schedules, and release activities
- Reviewed generated production and quality records to confirm compliance with GDP, traceability, and data integrity requirements
- Participated in process deviation and CAPA (Corrective Action and Preventative Action) processes, along with supporting timely closure of audit findings
- Ensured that only validated and calibrated equipment was utilised during production and quality-critical activities
- Contributed to the achievement of overall quality objectives and high levels of internal and external customer satisfaction
- Maintained strict adherence to SHEQ procedures, radiation safety requirements, nuclear license conditions, and facility operational safety limits at all times
- Ensured correct PPE usage and safe work practices during all operational, radiological, and nuclear medicine production activities
- Participated in SHEQ audits, safety event investigations, and corrective action implementation within agreed target dates
- Identified, communicated, and escalated potential safety risks, radiological hazards, and non-compliances proactively
- Contributed to achieving site safety objectives, including prevention of OTS violations, radiation-level-related incidents, and safety events
- Completed mandatory regulatory and safety training, including Radiation Worker, Noise Worker and Chemical Worker courses
- Segregated, controlled, and managed radioactive waste streams, including LLW, uranium residue, liquid waste, and dry solid radioactive waste, in compliance with approved waste procedures and facility license limits
- Managed 6-litre Hennies for dry solid radioactive waste, ensuring correct filling, tracking, storage, and compliance with maturity date and decay requirements
- Maintained accurate status tracking and documentation for liquid waste tanks, uranium residue logs, solid waste records, and Hennie maturity schedules
- Ensured adequate waste storage capacity was available prior to production start-ups, remaining within OTS and facility license limits
- Maintained high housekeeping standards within hot cells and production areas in accordance with API manufacturing, nuclear safety, and nuclear medicine production requirements
- Ensured cleaning SOPs for hot cells and processing equipment were implemented, verified, and documented effectively
- Demonstrated strong ethical conduct, accountability, and integrity in all professional activities
- Led by example in modelling organisational values, safety culture, and regulatory compliance expectations
- Communicated effectively across multidisciplinary teams, including production, engineering, quality, safety, radiation protection, and support functions
- Took ownership of assigned responsibilities and consistently met or exceeded performance expectations
- Demonstrated reliability in handling sensitive information, nuclear materials, company property, and regulated production environments
- Ensured personal training records remained current and that all tasks were performed only when fully trained, authorised, and competent
- Actively upheld NECSA SOC Ltd and NTP Radioisotopes SOC Ltd values, contributing positively to organisational culture, safety excellence, and operational reliability
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